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BioCardia, Inc. (BCDA)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was operationally strong: DSMB cleared CardiALLO to proceed with no treatment-emergent adverse events, Helix delivery showed clean safety in HF procedures, and CardiAMP HF II began enrolling at three sites; financially, revenue was $0 with net loss of $2.7M and cash used in operations of $1.6M .
  • EPS of -$0.59 missed the S&P Global consensus of -$0.39, and revenue remained at $0; burn remains modest but cash ended the quarter at $0.95M prior to a small post-quarter ATM financing .
  • Management is prioritizing regulatory paths: FDA and PMDA consultations for CardiAMP HF within roughly six months, plus U.S. Helix submission; CardiAMP HF II aims to fully enroll over ~2 years with quality-of-life replacing 6MWD in composite endpoints .
  • Near-term stock catalysts: PMDA acceptance to submit CardiAMP in Japan, U.S. Helix approval steps, CardiAMP HF II site activation/enrollment updates, and CardiALLO dose-escalation progress .

What Went Well and What Went Wrong

What Went Well

  • CardiALLO HF DSMB low-dose review reported no treatment-emergent adverse events (arrhythmias, rejection, allergic responses) and recommended the study proceed, de-risking allogeneic platform safety .
  • Helix delivery safety in CardiAMP HF showed no procedure-related deaths, embolism, or need for surgical/endovascular repair, supporting a U.S. approval submission .
  • CardiAMP HF II trial is actively enrolling at three U.S. sites, with FDA-blessed design tweaks (QoL in composite endpoint; personalized dosing to include more patients), improving power and enrollment feasibility; physician feedback on Morph DNA was notably positive (“I love Morph DNA”) .

What Went Wrong

  • CardiAMP HF I did not meet the primary endpoint due to the third-tier 6MWD component despite strong Tier 1/2 signals; the composite reached significance only in NT-proBNP-elevated subgroup with QoL as Tier 3 (p=0.02), necessitating HF II confirmation .
  • Financially, revenue remained $0 while net loss widened YoY ($2.7M vs $2.3M), and EPS missed consensus; cash balance was low at quarter-end, requiring post-quarter ATM financing .
  • Balance sheet showed stockholders’ equity deficit (-$1.52M) and current liabilities > current assets, highlighting financing risk amid ongoing development timelines .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD)$0 $0*$0
R&D Expense ($USD)$931,000 N/A$1,530,000
SG&A Expense ($USD)$825,000 N/A$1,196,000
Total Expenses ($USD)$1,756,000 N/A$2,726,000
Operating Loss ($USD)$(1,756,000) N/A$(2,726,000)
Net Loss ($USD)$(1,737,000) N/A$(2,712,000)
EPS (Basic & Diluted)$(0.61) $(0.25)*$(0.59)
Net Cash Used in Operations ($USD)N/AN/A$1,600,000
Cash & Cash Equivalents ($USD)$4,930,000 N/A$949,000

Notes: *Values retrieved from S&P Global.

KPIs and Balance Sheet

KPI / BalanceQ3 2024Q4 2024Q1 2025
CardiAMP HF II: Active sitesN/AN/A3 sites
CardiALLO HF: DSMB low-dose outcomeN/AN/AProceed; no TEAEs
Helix delivery safety in HFN/AN/ANo procedure-related major events
Total Assets ($USD ‘000s)$6,267 $3,724 $2,166
Current Liabilities ($USD ‘000s)$2,840 $2,321 $3,234
Stockholders’ Equity (Deficit) ($USD ‘000s)$(2,753) $837 $(1,520)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
R&D Expense TrajectoryFY 2025N/A“Increase modestly” as programs advance in U.S. and Japan Raised
SG&A Run-RateFY 2025N/A“Track closely” to 2024 levels Maintained
CardiAMP HF II Enrollment~2 yearsN/AExpect full enrollment over ~2 years; 250 patients, 1:1 randomization New operational guidance
Regulatory MilestonesQ2–Q3 2025N/ASubmit CardiAMP HF results; FDA and Japan PMDA consultations, and U.S. Helix submission New milestones

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Regulatory (FDA/PMDA)PMDA consultation scheduled; pathway may allow approval based on U.S. data Plan to share 2-yr data; optimism on FDA/PMDA paths ~6-month timeframe to clarity on PMDA submission; FDA consultation planned Intensifying focus; nearer milestones
Trial Design & EnrollmentHF II protocol amendment to include more patients; site onboarding QoL as Tier 3, NT-proBNP subgroup significant; HF II activation HF II enrolling at 3 sites; personalized dosing; QoL metric replaces 6MWD Execution underway
SafetyN/AHF I showed reduced arrhythmias trend CardiALLO DSMB positive; Helix procedure safety clean Strengthening safety profile
Partnerships/BDActive discussions across platforms Positioning for partnerships on all platforms Multiple large-cap strategics in Morph; open partnering across CardiALLO/Helix/CardiAMP Ongoing; potential catalysts
Pricing/Tariffs/MacroN/AN/AMFN/tariffs seen as low impact; value pricing target ~$20k with >90% margins Clarified pricing strategy
Device Platforms (Helix/Morph DNA)FDA clearance for Morph DNA; commercialization prep Morph DNA first commercial units built Helix approval pursuit; Morph DNA used in trials; strong physician feedback Commercialization inching forward

Management Commentary

  • “CardiAMP heart failure trial results demonstrated both safety and meaningful benefits... Our top priority... is all about sharing this data with the Food and Drug Administration and Japan's PMDA to align on pathways” .
  • “The absence of any adverse events in these very ill patients was great news to confirm for this off-the-shelf therapy” (CardiALLO low-dose cohort) .
  • “Helix... potential to be the first approved transendocardial biotherapeutic delivery system in the United States... because of the CardiAMP heart failure data” .
  • “We actually think we can have greater than 90% margins at that price point [~$20,000]” (CardiAMP pricing strategy vs MFN/tariffs) .
  • “After the recent quarter, management chose to do a small financing at the market with minimum dilution… We don't have a large burn rate” .

Q&A Highlights

  • Business development maturity: active discussions with large-cap strategics around Morph; openness to partnering across CardiALLO/Helix/CardiAMP, with Japan distribution to be partnered post-approval .
  • Japan PMDA process: PMDA acceptance to submit viewed akin to FDA accepting a BLA; management targets ~6 months to clarity on submission timing .
  • CardiAMP HF II clarity: QoL metric replacing 6MWD; personalized dosing via pre-procedure screening to include more patients; 250 patients, 1:1 randomization, ~2-year enrollment target .
  • Pricing/tariffs: MFN/tariffs expected to have minimal impact; aiming value-based pricing (~$20k/patient) with strong margins; most manufacturing U.S.-based .

Estimates Context

  • Q1 2025 EPS of -$0.59 vs consensus -$0.39*; revenue actual $0 vs limited coverage for Q1 revenue estimates. Q4 2024 had -$0.25 actual EPS vs -$0.625* consensus; Q3 2024 -$0.61 actual EPS vs -$1.19* consensus.
  • Given continuing $0 revenue and modest burn, near-term estimate adjustments likely center on timing of regulatory outcomes and trial enrollment cadence rather than revenue inflections.
    Notes: *Values retrieved from S&P Global.

EPS vs Consensus

PeriodEPS Actual ($USD)EPS Consensus Mean ($USD)Beat/Miss
Q3 2024-0.61 -1.19*Beat (less negative)
Q4 2024-0.25*-0.625*Beat (less negative)
Q1 2025-0.59 -0.39*Miss (more negative)

Revenue vs Consensus

PeriodRevenue Actual ($USD)Revenue Consensus Mean ($USD)Beat/Miss
Q3 2024$0 $200,000*Miss
Q4 2024$0*$22,500*In line/Miss (immaterial)
Q1 2025$0 N/AN/A

Notes: *Values retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term catalysts are regulatory: PMDA clarity on CardiAMP submission within ~6 months and FDA consultations are likely to drive sentiment; monitor formal consultation scheduling and minutes .
  • CardiAMP HF II design changes (QoL endpoint, personalized dosing) address HF I limitations and should improve enrollment/power; watch monthly site activation and enrollment pace .
  • Helix U.S. approval pathway and Morph DNA adoption can unlock device-platform optionality (partnering/divestiture) and provide non-dilutive capital avenues .
  • Allogeneic platform de-risked on safety at low dose; progression to higher-dose cohorts could become a valuation lever if efficacy signals emerge .
  • Financial risk persists: zero revenue, low cash at quarter-end ($0.95M), and equity deficit (-$1.52M) underscore dependence on financings/partnerships; expect further capital actions as milestones approach .
  • Estimate revisions: Q1 EPS miss may prompt near-term downward adjustments; medium-term upside depends on regulatory path acceptance (Japan/U.S.) and HF II enrollment momentum.
  • Trading stance: stock likely reacts to PMDA acceptance-to-submit and Helix approval steps; downside risk tied to regulatory delays or enrollment bottlenecks; upside tied to formal regulatory progress and partnering announcements .